DIETARY SUPPLEMENTS

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FDA Targets Highly Concentrated Caffeine in Dietary Supplements

Posted on April 17, 2018

As previously reported on this blog in 2015, FDA warned that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” The Agency

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FDA Issues First Ever Mandatory Recall Order for Kratom Products

Posted on April 4, 2018

On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for

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Consent Decree of Permanent Injunction Against Wholesale Manufacturer of Dietary Supplements

Posted on April 2, 2018

In a March 29, 2018 press release, the Food and Drug Administration (FDA) announced a consent decree entered by the US District Court for the Eastern District of New

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FDA oversees destruction and recall of kratom products

Posted on February 22, 2018

On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names

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FDA Announces October Meeting on Pre-DSHEA List

Posted on September 6, 2017

Manufacturers or distributors of new dietary ingredients (NDIs) must submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary

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FDA Launches “Organ Chip” Project to Support Food and Dietary Supplement Safety Research

Posted on April 14, 2017

“Organs-on-Chips” technology has been the focus of a public-private collaboration between FDA, the federal Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH). “Organs-on-Chips” essentially involves

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FSMA, Nutrition Panel Changes among Burdensome Federal Regulations, Industry Tells DOC

Posted on April 4, 2017

Members of the food and dietary supplement industries were among those who responded to a March 9, 2017 request from the U.S. Department of Commerce (DOC) for input on the

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Supplement Spotlight: FDA Revised NDI Draft Guidance Does Not Alleviate Industry’s Concerns

Posted on January 17, 2017

As previously reported on this blog, FDA issued a revised Draft Guidance titled, “Dietary Supplements: New Dietary Ingredient [NDI] Notifications and Related Issues,” in August 2016. The Agency received…
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Extension to Vinpocetine Comment Period Requested

Posted on October 13, 2016

The Natural Products Association has asked FDA to extend the comment period deadline concerning the regulatory status of vinpocetine until September 6, 2017.

Vinpocetine is a semisynthetic derivative of the

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FDA Requests Comments on Regulatory Status of Vinpocetine

Posted on September 8, 2016

FDA has requested comments on its “tentative conclusion” that vinpocetine is not eligible for use as a dietary ingredient.

Vinpocetine is a semisynthetic derivative of the vinca alkaloid vincamine, an

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